This Means War

[rory_20_uk]

What I don't understand is how Monsanto can corrupt them and Big Pharma hasn't. Its not like they're short on money: each company R&D budget is billions a year, and there are a lot of companies. One drug can earn them billions a year in turn.

I don't think you've any concept in how much testing goes on with drugs, nor how difficult it is to stop one being released when the event occurs in less than 1 in 10,000 and often after a length of time in a certain demographic of patients. Oh, and then find that needle from all the background adverse events that are not related... I think your last sentence shows your complete lack of understanding.

[a completely inoffensive name]

What I don't understand is how Monsanto can corrupt them and Big Pharma hasn't. Its not like they're short on money: each company R&D budget is billions a year, and there are a lot of companies. One drug can earn them billions a year in turn.

I don't think you've any concept in how much testing goes on with drugs, nor how difficult it is to stop one being released when the event occurs in less than 1 in 10,000 and often after a length of time in a certain demographic of patients. Oh, and then find that needle from all the background adverse events that are not related... I think your last sentence shows your complete lack of understanding.

Wait, who said Big Pharma hasn't? As far as I know, there must be a reason why the US has a problem with how expensive our drugs are compared to other countries. (Although whatever happened to all those stories of people crossing into canada for prescription drugs?)

I admit that I don't know much about the industry. That's specifically why I added that last sentence in there. I understand there is a lot of testing, don't get wrong. I am not saying they create a drug and then start pumping it out into the market immediately. I am just saying that perhaps because making new drugs is an expensive business that the testing is still not as long as it could be because companies do have an incentive to make new products before the patents on their old ones expires. That's all I am saying. Not dissing the hard work people do in Pharma testing labs. To be honest, I don't know the threshold of what crosses the line from "acceptable" into, "we should recall this". If you could enlighten me on this, that would be wonderful. I am just commenting on how I see a news scare every six months or so about the recall of some drug or another (wasn't something called Vioxx or something a big one?) and I wonder how this kind of stuff manages to slip by. Forgive me if I insulted you with my ignorance.

EDIT: yeah here is an article of a judge in australia saying that Vioxx was unfit to sell. http://www.theage.com.au/national/dr...0305-powh.html

[rory_20_uk]

NP, it's rare there's something I do know something about... I get rather sensitive as I perceive my industry to get more flack than British Aerospace et al who build weaponry for money, and all we do is try to make pills and potions to make people better to make money. Angels? No, we're not. Devils? No, we're not that either.

Like most things in Medicine it's a balancing act between several variables.

Longer trials will probably pick up more adverse events. But it increases the cost of the drug as trials are very expensive
More people in the trials will also pick up more adverse events. But increases the cost of the drug as this increases the cost of the trials.
More groupings (age, race, gender, weight, kidney function, diabetes, cardiovascular disease... I could go on)? Again this would require more people for there to be enough in each group to make it worthwhile.
Indirectly, if more drugs were binned due to this it would further increase the costs of drugs as fewer would make it.

A "signal" in a drugs trial is 3 in 10,000. An arbitrary value - but where does random chance end and adverse reaction start? Difficult to know.

Most drugs also go after-market surveillance every 6 months for 5 years (then yearly). This is how drugs are found to have very low levels of side effects, or side effects in a group of patients who were not directly assessed. If there are worries, then more frequent or targeted surveillance is undertaken.

The other side of the coin is: how many die because a drug is not released? The NNT to NNH ratio? (Not that investigators ever do this by the way). If 10 are needed to save someone who would have died, but 1000 to kill someone who would have lived, one might dispassionately say that is acceptable. But deaths of 1 in 1,000 is a drug recall / catastrophe - even if it saved loads of other people (only the case in areas such as antibiotics or similar).

Most agencies will get clobbered for passing anything that turns out to be harmful, but not rewarded for passing something.

The study was in 2000 - but it was approved in 1999. So at the time of approval neither the company nor the FDA knew about this problem. I agree that a 500% increase in MI risk is a LOT. I am sure that the company's senior Execs were reluctant to let $2.5bn a year walk out the door by recalling (and I would also hasten to add that post-marketing business decisions are a long way from the pre-registration Doctors and Scientists). And so faffed around for a long time. Perhaps they hoped another study would show a lower risk? Who knows?

Edit: Linkey Looks like it's a class effect.

[Greyblades]

Hmm, I wonder, do they slacken the restricions on how many survive in a thousand if the drug is only going to be used on an always fatal disease?

[rory_20_uk]

There is the Orphan drug designation, and there is some pragmatism in e.g. Oncology - look at the SPC for any oncology drug and the side effects are very long - but you're dead otherwise.

Orphan drugs again hat more lattitude as there's otherwise nothing else. I still don't think there is a view taken that as long as more are saved than killed compared to standard treatment it is allowed.

The interesting thing is that regulations are tightened up all the time - but once you're passed that's it barring disasters, so many old drugs would never have passed today (paracetamol, aspirin to name two).

[a completely inoffensive name]

There is the Orphan drug designation, and there is some pragmatism in e.g. Oncology - look at the SPC for any oncology drug and the side effects are very long - but you're dead otherwise.

Orphan drugs again hat more lattitude as there's otherwise nothing else. I still don't think there is a view taken that as long as more are saved than killed compared to standard treatment it is allowed.

The interesting thing is that regulations are tightened up all the time - but once you're passed that's it barring disasters, so many old drugs would never have passed today (paracetamol, aspirin to name two).

How would aspirin not pass regulations today? As far as I know, it is recommended to take a tiny amount every day and there is no side effects unless you decide to take 20 of them.